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The XIA® 4.5 Spinal System is interior/anteriolateral and posterior, non-cervical pedicle and non-pedicle fixation for the following indications: • Degenerative Disc Disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) - · Spondylolisthesis - · Trauma (i.e. fracture of dislocation) - · Spinal Stenosis - · Curvatures (i.e. scoliosis, kyphosis, and/or lordosis) - Tumor - Pseudarthrosis - · Failed Previous Fusion The Stryker Spine DIAPASON® Spinal System, Opus® Spinal System, and XIA® 4.5 Spinal System can be linked to the XIA® 4.5 Spinal System via the rod-to-rod connector when used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. Except for the staples, when used for posterior non-cervical pedicle screw fixation in pediatric patients, the XIA® 4.5 Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the XIA® 4.5 Spinal System is intended to treat petients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The subject devices consist of a variety of multiple component spinal fixation systems intended for use as an adjunct to fusion. These devices have been previously cleared by FDA. The primary purpose of this submission is to establish an MR Conditional labeling claim for these implants.

The Stryker Spine Sierra Mertz family of spinal implant systems (referred to as "the subject devices" in the document) is seeking an MR Conditional labeling claim.

Here's an analysis of the acceptance criteria and study proving device conformance, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated in the provided text. The document refers to "the subject devices" which is a family of 20 different spinal systems. It's implied that various components within these systems were subjected to testing.
• Data Provenance: The document does not specify the country of origin of the data. The study was a prospective test conducted to establish MR Conditional labeling for the devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This is not applicable as the study involved physical testing for MR compatibility according to a standard (ASTM F2503), not human expert evaluation of medical images or data.

4. Adjudication Method for the Test Set

This is not applicable for this type of physical device testing. The results are based on adherence to the parameters set by the ASTM F2503 standard.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This is not applicable. The submission is for spinal implants and their MR compatibility, not an AI-powered diagnostic or assistive tool for human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable, as the device is a physical spinal implant system, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the test was compliance with the ASTM F2503 standard for MR compatibility. This standard defines specific parameters and limits for evaluating the safety and performance of medical devices in an MRI environment, such as magnetic field interactions, RF-induced heating, and image artifact.

8. The Sample Size for the Training Set

This is not applicable. This is a medical device clearance for physical implants, not a machine learning or AI model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This is not applicable. As stated in point 8, there is no training set for this type of device submission.

Summary of the Study Proving Device Meets Acceptance Criteria:

The study performed was a MR Compatibility testing per ASTM F2503. The FDA document states: "The test results demonstrate that the subject devices performance met the prescribed acceptance criteria and are substantially equivalent to the predicate devices." This indicates that the physical and electrical properties of the spinal implant systems, when subjected to MRI conditions outlined in the ASTM F2503 standard, did not pose unacceptable risks (e.g., excessive heating, dangerous magnetic force, or significant image artifacts) and thus were deemed MR Conditional. The purpose of this testing was to establish the MR Conditional labeling claim for the devices.

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The Xia® Growth Rod Conversion Set is indicated in patients with potential for additional spinal growth under 10 years of age who require surgical treatment to obtain and maintain correction of severe, progressive, life-threatening, early-onset spinal deformities associated with thoracic insufficiency, including early-onset scoliosis. The Xia® Growth Rod Conversion Set may be used with any cleared Xia® 4.5 Spinal System rod construct. The Xia® Growth Rod Conversion Set is not intended for use in conjunction with staples.

The Xia® Growth Rod Conversion Set consists of connectors designed to convert a traditional fusion construct into a non-fusion growth enabling construct that can be surgically lengthened on a periodic basis as the patient grows. The Xia® Growth Rod Conversion Set components are manufactured from titanium alloy and are designed to interact with constructs consisting of hooks, screws, connectors, and 4.5mm diameter rods. The Xia® Growth Rod Conversion Set is intended for use only with Xia® 4.5 Spinal System fusion constructs cleared for pediatric use.

The provided text describes the Xia® Growth Rod Conversion Set, a medical device. However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria in the context of diagnostic performance (e.g., accuracy, sensitivity, specificity for an AI-powered device).

This document is a 510(k) premarket notification for a medical device (Xia® Growth Rod Conversion Set), which primarily focuses on demonstrating substantial equivalence to a predicate device.

Specifically, the "Summary of the Performance Data" section (Page 4, Table "510(k) Summary") states:
"Engineering analysis demonstrated that introduction of the Growth Rod Conversion Set does not adversely affect performance of the Xia® 4.5 Spinal System and does not represent a new, worst case scenario. No additional performance data was provided."

This indicates that the "study" conducted was an engineering analysis to ensure the new component does not negatively impact the performance of an existing, cleared system, rather than a clinical study evaluating diagnostic accuracy or a specific set of performance metrics against acceptance criteria.

Therefore, I cannot provide the requested information as it is not present in the provided text. The document is about a different type of medical device review process (510(k) for a physical implantable device) that relies on substantial equivalence and engineering analysis, not diagnostic performance metrics or human reader studies.

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